Rajeev Sharma
Associate Director, Drug Safety and Pharmacovigilance
- Role
- Associate Director, Drug Safety and Pharmacovigilance at Syneos Health
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
About Rajeev Sharma
Seasoned professional with extensive experience as a liaison between Company, sponsors, vendors, and internal departments, driving excellence in Safety and Pharmacovigilance operations and business development. Comprehensive experience across the entire lifecycle of pharmacovigilance operation. Proven expertise in managing cross-functional teams, engagement in bid defense meetings, business development, aligning safety procedures, and ensuring compliance with industry regulations. Adept at overseeing projects, enhancing operational efficiency, and fostering collaborative relationships. Exceptional leadership, communication, and strategic planning abilities. Primarily involved in project delivery, vendor negotiation and management, inspection and audit readiness. Creation, and maintenance of SOPs for Pharmacovigilance function in alignment with EMA, US FDA and other global regulatory bodies. During the course have delivered and worked for major pharma giants.Expertise gained in the domain and its various aspects especially, Clinical data review from trials, ICSR processing, literature searches (global and local), search string creation/validation, screening and review of scientific databases for adverse events. Overseeing deliveries from team involved in creation, maintenance, validation and updating of search strings, ICSR case processing from spontaneous/solicited/study and literature, narrative writing, MedDRA coding, follow up activities, team management, client interactions and project management. A good knowledge and in depth understanding of 21 CFR part 11, GVP guideline acquired on job and have hands on experience of major databases such as ARGUS, ArisG and Adis including literature databases Embase, PubMed Ovid etc. Undertaken projects related transitions related to technical upgrades of the database including WHO DD upgrades, MedDRA updates and trained the teams on the same.
Experience
Associate Director, Drug Safety and Pharmacovigilance
Jul 2025 — Present · IN
Education
LNCT Group of Colleges
Doctor of Philosophy - PhD, Pharmacology
LNCT Group of Colleges
Master's degree, Pharmacology
1991 — 2003
Dr. A.P.J. Abdul Kalam Technical University
B.Pharm, Pharmacy
2005 — 2009
St.Joseph's school Shaktinagar Sonebhadra
High School; C.B.S.E, Physics,Chemistry,Biology,English
1990 — 2003
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